We have learned that Time-Cap Labs, producer of a generic version of the brand name drug Armour, a natural and bioidentical thyroid replacement, has been ordered by the FDA to stop production. The FDA has decided to classify the company’s product, available for over a century, as an unapproved new drug. Since the new drug approval process is prohibitively expensive for a non-patentable substance, the FDA is in effect banning the natural product. The purpose? Presumably to protect the profits of other, inferior drugs that have been FDA approved.

According to statistics by the American Association of Clinical Endocrinologists and other medical organizations, approximately twenty-seven million Americans have a thyroid disorder. Thyroid consumer advocate Mary Shomon projects that 2 million of these patients take either Armour Thyroid or a generic equivalent.

Armour and other “whole” natural thyroid preparations (including Westhroid and Nathroid as well as Time-Cap Lab’s Thyroid) are bio-identical, complete hormone preparations, containing “T4” “T3” “T2” and “T1” in the same proportions made by the human thyroid.

The FDA approved preparations Synthroid (T4), Cytomel (T3), and Levethyroxine (T4) include bio-identical molecules, but are not complete or totally bio-identical as they do not contain “T2” or “T1”. It’s no wonder so many people feel much better with the balanced natural products that have been available for generations.

As famed physician Dr. Jonathan Wright observes: “Natural thyroid has never killed or severely harmed anyone since its first use in the 1890s, prior to the FDA itself. It is a mainstay not only in the treatment of hypothyroidism but also in ‘healthy aging’ therapy. That the FDA should even be thinking of requiring a new drug approval for a safe, 100 plus year old natural treatment is outrageous.”

We will report further as soon as we confirm more of the facts, and as always, we’ll let you know how you can get involved.

Most people would not dream of directing a cardiologist how to perform cardiopulmonary resuscitation during a cardiac arrest. They also would not come in to see the surgeon with a specific outline on how to do the procedure. Most would decline to have their surgery done in the same way and with the same techniques as in the 1970s. Despite this, many intelligent, otherwise reasonable people have no hesitation trying to “teach” me about the thyroid. Many of these same people also request to have their thyroid disorder managed similar to how we did decades ago.

Why is this?

There are several reasons. For one, despite the advances made in technology, scientific knowledge and outcomes over recent decades, modern medicine has failed many patients from a humanistic perspective. It is not too much to expect for questions to be answered and treatment options explained. Everyone desires to be listened to and heard. There is nothing more discouraging than when one’s symptoms are ignored. I have witnessed this myself when I and family members have been patients. It is extremely frustrating. Not surprisingly, some pursue alternative options.

Some believe in a more natural approach towards health. Their goal is to minimize the synthetic, processed and man-made. I actually understand this philosophy very well. My family and I grow a large portion of our vegetables organically. We enjoy the sense of connection with the land and the seasons. We take pride in knowing that we participated in the sustainable production of our food. If someone presented to us a well-crafted, scientifically valid argument as to why there is no benefit to organic vs. conventional gardening, we would smile, nod and keep doing what we are doing. We garden organically as much on philosophical grounds as any other reason.

For me to argue for patients to change someone’s belief system based on science is equivalent to attempting to convince them to change their religion or political party on the same grounds. It would be futile as well as absolutely inappropriate.

Health care is different, however, because there is the potential for harm as well as benefit. I am obliged to inform my patients about the positive as well as negative potential consequences of one option over another. This is true no matter if we are discussing alternative vs. more mainstream therapies. However, I realize that I am only one advisor among many. My duty is to provide the most accurate information possible. Patients are free to choose for themselves how they would like to proceed.

Finally, last week I saw a woman who had been on desiccated thyroid for decades. I explained that we now prefer levothyroxine instead of desiccated thyroid. I also quickly pointed out that her thyroid-stimulating hormone has been perfect, between 0.7 mIU/L and 1.0 mIU/L over the last several years. She had no symptoms; it was difficult for me to argue with success. After discussing and asking her what she wanted to do, she left my office still on desiccated thyroid.

Comment by Tom Repas DO FACP FACE CDE — June 12, 2009 12:24 PM

Hello all – I continue to read the comments posted on this and related threads.

I appreciate everyone sharing their insights and experiences. I haven’t responded to every single posted comment because the sheer volume makes it impossible.

I also get the impression that no matter what else I might add, it would be futile and encourage only further attacks.

I confess to purposely choosing a subject which many are passionate about — and which many of my peers avoid discussing at all.

However, if we take our respective positions, dig our heels in and never talk to those with differing opinions, how will medical care ever progress and improve?

Rather than avoiding talking about such topics, I usually prefer to meet them head on and encourage — not discourage — conversation. I’ll do that even if I know that everyone does not agree with me. I could have written about something or taken a position that everyone agrees with — but that would have been too easy.

Several endocrinologist colleagues have told me I’m crazy for writing about such a sensitive issue and in a way that I know would be sure to make me a target.

They are probably correct — but then I’ve never been known to be one who takes the easiest route, simply because is it easy. Don’t forget, I run ultramarathons in my spare time because marathons are “too easy.”

We might not agree on many things but I appreciate everyone sharing their thoughts, opinions and experiences. It actually has helped me in discussing this issue with patients in my own practice.

You have been heard — loud and clear.

Thank you all again for commenting.

(Please DO NOT accuse me of being patronizing — I sincerely do appreciate your comments, even if they differ from my own).

Most board-certified endocrinologists avoid desiccated thyroid in the management of hypothyroidism for additional reasons.

Desiccated thyroid preparations contain an approximately 4:1 ratio of thyroxine (T4) to triiodothyronine (T3), whereas the normal human thyroid has of a ratio of 11:1. These preparations result in supraphysiologic levels of T3 in the two to four hours after ingestion. This is due to the rapid release of T3 from thyroglobulin and the immediate almost complete absorption of T3.

In my own practice, I have seen numerous individuals referred to me on desiccated thyroid with fully suppressed thyroid-stimulating hormone. This is because the dose was titrated based on symptoms or clinical findings rather than biochemical assays. Some have had anxiety, insomnia, tremulousness, heat intolerance and other symptoms clearly due to iatrogenic hyperthyroidism. The long-term consequences of hyperthyroidism are not benign. Nevertheless, many have absolutely refused to allow me to decrease their dose, despite my concerns.

With hormone therapy, just as too little is unacceptable, too much is also unacceptable. More is not always better.

Some alternative care practitioners claim that standardized laboratory testing is unreliable. They use other methods to justify their approach such as basal body temperature measurement, testing of tendon reflexes and how the patient generally feels subjectively.

Although thyroid hormone certainly has effects on metabolism, in order for there to be a consistently measurable increase in body temperature, many patients must be rendered hyperthyroid. There are many other factors that affect basal body temperature, not only the thyroid. In addition, there is wide intra-individual variation in body temperature. Body temperature varies depending on time of day and how it is measured. “Normal” body temperature should not be defined as 98.6º F ± 0º, just as we do not define “normal” TSH as exactly 1.00 mIU/L. Normal is a range, not a single value. Using basal body temperature to modify the dose of thyroid HT is imprecise and not supported by the scientific evidence. It is the same with measurement of reflexes and other non-specific clinical findings.

Regarding symptoms and the subjective feeling of wellness, that is problematic. My goal is not only to prevent and treat disease, but for all of my patients to feel better on whatever therapy we have chosen. The problem here is that there are innumerable reasons to feel poorly, often with identical symptoms to hypothyroidism, and yet not due to thyroid dysfunction.

Too many times have I seen other medical diagnoses missed, because every symptom a patient had was attributed to their thyroid and no further evaluation was done. It is easier and less time consuming to write a prescription than it is to think, ask questions and most important of all … to listen.

Sometimes we need to tell patients what they need to hear, even if it is not what they would like to hear. This should be done as kindly and tactfully as possible, but it must be done nonetheless.

Before I go any further, I must disclose: I do not use desiccated thyroid (Armour Thyroid, Forest Laboratories Inc.) in the management of hypothyroidism. Like most of my endocrinologist peers, I believe that desiccated thyroid is antiquated therapy and should no longer be used. Guidelines published by the American Association of Clinical Endocrinologists and other major endocrinology professional organizations support this position.

However, I am frequently asked by my patients about desiccated thyroid. Some of them tell me that a family member, friend, alternative care practitioner or other acquaintance has told them they do not “believe” in levothyroxine and advised them to be switched. This, along with several negative comments by patients on this blog about levothyroxine, is why I chose to write about this issue in detail now.

Desiccated thyroid is made from dried and powdered animal thyroid gland, a by-product of domesticated animals raised for the meat industry. For many years in the past, it had been successfully used in the management of hypothyroidism. However, once levothyroxine became available, desiccated thyroid fell out of favor. Recently, there has been resurgence in the use of desiccated thyroid as alternative medicine practitioners have proclaimed the benefits of natural over synthetic thyroid hormone preparations.

So why do I and most other endocrinologists refuse to use desiccated thyroid?

There are a number of reasons. First and foremost, desiccated thyroid preparations have an unacceptable level of variability batch to batch, often resulting in unacceptable variation in thyroid-stimulating hormone. The current USP standards specify that the amounts of levothyroxine and liothyronine in each 65 mg of desiccated thyroid should be 38 mcg and 9 mcg; however, the actual amounts vary considerably. According to the American Society of Health-System Pharmacists “Big Red Book,” the mean concentrations of levothyroxine and liothyronine in each 60 mg of desiccated thyroid ranged from 8.8 mcg to 59 mcg and 7.9 mcg to 18 mcg, respectively.

Part of the problem is that many manufacturers have used iodine content rather than actual thyroid hormone to standardize their preparations. Some manufacturers (ie, Armour Thyroid) perform bioassays to maximize batch-to-batch reproducibility. However, as noted above, the range of levothyroxine and liothyronine can vary considerably, even in products standardized by bioassay instead of iodine content.

I and many endocrinologists are concerned when the brand of levothyroxine is switched without our knowledge to other brands or from brand to generic. Whenever a patient must be switched from one levothyroxine product to another, we always recheck the TSH in several weeks to confirm the dose remains optimal. Even as little as a 10% difference between similarly labeled levothyroxine products can result in large variation in clinical response as measured by TSH. When managing my patients on levothyroxine, sometimes I change the dose by as little as an extra half pill more or less per week

If we consider slight variation between various levothyroxine products to be clinically important, then the much larger variation within desiccated thyroid preparations is unacceptable.

We do not want politicians rationing our medical care and telling people that they are somehow too old or too sick for treatment. We do not want politicians deciding which treatments will be available, and which will not.

Whom do we trust more: our doctors or our politicians? Of course we trust our doctors more than our politicians. We must keep and defend our freedoms, starting with our most fundamental freedom to choose the medical care that we need most.

The bill that is passing through the House committees is a complete government takeover of medicine that will restrict our choices and lower the quality of care. HR 3200, misleadingly entitled “America’s Affordable Health Choices Act of 2009,” takes away the choice and control that Americans have today over their medical treatment. People will be told under the bill that abortion is covered at taxpayer expense, but some life-saving or life-enhancing treatments are not.

The Obama bill imposes a “public option” that will define which treatments will be allowed. Your access to bio-identical hormones will probably be rejected by the public option, and that could squeeze out even private access to these helpful treatments.

The bill would force people to buy insurance they do not need, and which will not cover what we do need. Taxpayers will be forced to buy that insurance for those who cannot, at a trillion-dollar expense that will bankrupt the government.

The bill requires that government investigate “self-insured employers not being able to pay obligations.” This means government will audit and harass small business owners until they pay for insurance they cannot afford.

The government will dictate the health benefits that must be included by insurance as a condition of being able to participate in the Health Insurance Exchange. The private insurance will have no reason to differ from the public option, and private insurance will soon disappear.

Families with special needs could be hit hardest by this new health bill. In America children with cystic fibrosis live an average of 37 years, but under nationalized health care the life expectancy for this condition is only 27 years in Ireland. That’s because government-run health care does not cover many special-needs conditions, and there is not enough of a private market to fund such care after the government takes over.

No one expects the U.S. Post Office to be innovative, and it isn’t. In fact, Post Offices are shortening their hours because they can’t make ends meet. The Post Office did not develop Federal Express, cell phones, and the internet. Do we want medical care in our nation to become like the Post Office? Do we want to kiss goodbye to medical innovation, like possible cures for cancer and other life-saving medical treatments?

Keep the government out of medical care and let the free market work its magic. Return the money to patients so that private medicine can develop the new cures.

The bottom line is that the Obama health care bill gives almost total control to government politicians and bureaucrats to deny you medical care you need. Everyone must say “no” to this government takeover of medicine.

What you can do now:

Go to http://www.house.gov/ and type in your zip code in the upper-left corner to find the Congressman representing you. When their name pulls up, click on it to get to their website. There should be a tab for their district office.

Please call, email, or visit your Congressman while they are in recess this month so they know how you feel about Obama’s plan. Attend town hall meetings in your district like this one, where an ordinary citizen received a thunderous applause for saying: “I look at this health care plan and I see nothing that is about health or about care. What I see is a bureaucratic nightmare, senator. Medicaid is broke, Medicare is broke, Social Security is broke and you want us to believe that a government that can’t even run a cash for clunkers program is going to run one-seventh of our U.S. economy? No sir, no.”

Miami, FL (PRWEB) October 19, 2007 — Renowned weight loss doctor and author Sanford Siegal, D.O., M.D., best known as the creator of the popular Dr. Siegal’s COOKIE DIET™ weight loss system, applauds the sudden renewed interest in hypothyroidism. Hypothyroidism is an often undiagnosed disease that slows metabolism and causes a host of cruel symptoms including depression, dry skin, infertility and, most notably, obesity. In his most recent book, Is Your Thyroid Making You Fat? (Warner Books, 2000), Dr. Siegal takes issue with his fellow physicians who he says rely too heavily on questionable laboratory tests and ignore the obvious signs of a metabolic problem in their overweight patients.

“I’ve treated more than a half million overweight patients during the past fifty years. I’ve ordered thousands of thyroid lab tests and I can tell you they are highly unreliable,” said Dr. Siegal. “I’ve ordered the same test on the same person several days in a row and gotten widely conflicting results.”

During an appearance on ABC’s Good Morning America in 2003, Dr. Siegal told host Charles Gibson that he estimates that one out of four overweight patients come to him with a thyroid problem that has gone undiagnosed by their family physicians.

Dr. Siegal has developed his own self-test for determining hypothyroidism which he claims is more accurate than conventional tests. The test, which appears in his book, involves evaluating the patient’s weight loss while on a fixed calorie diet and comparing that result with the expected standard.

According to Dr. Siegal, many overweight people truthfully tell their family doctors that they don’t overeat and yet can’t lose weight even on a low calorie diet. Often doctors don’t believe their patients and accuse them of overeating.

“I’ve received thousands of emails and letters from readers who said that they felt vindicated when they read the book,” added Dr. Siegal. “For years, they’d been told that their obesity, depression, and other medical problems were caused by their lack of willpower when, in fact, the culprit was a sluggish metabolism.”

In addition to his concern about the methods some of his colleagues use to diagnose hypothyroidism, Dr. Siegal is equally critical of the most commonly prescribed medication for treating the problem, levothyroxine. According to Dr. Siegal, this synthetic form of thyroid hormone is less effective than the natural form known as Armour thyroid or Thyroid USP.

“The tragic thing about undiagnosed hypothyroidism and the devastating effects it has on millions of lives is that it is generally easy to treat with natural thyroid hormone, an inexpensive, well-tolerated medication,” added Dr. Siegal.

ABOUT SANFORD SIEGAL, D.O., M.D.

Dr. Sanford Siegal is a practicing physician whose Miami, Florida-based medical practice, Siegal Medical Group, has treated obesity exclusively since 1960. He is the author of several books on topics ranging from high fiber dieting to drug-free hunger control to hypothyroidism. Dr. Siegal is frequently the subject of news reports and has been profiled by Fox News Channel, CNN, Woman’s World, It’s Your Call with Lynn Doyle and many other media outlets.

RLC Labs, the manufacturer of the natural desiccated thyroid drugs Nature-Throid and Westhroid, announced today that their products are currently on back-order. In recent months, shortages of Armour Thyroid during their reformulation caused a large increase in demand for Nature-Throid and Westhroid (which are identical products). After patients reported problems with the reformulated Armour, and many experienced worsening symptoms, an additional demand was put on RLC as patients were switching from Armour Thyroid to Nature-throid and Westhroid. RLC has attempted to ramp up production, but a shortage of raw materials — the “Thyroid USP” desiccated powder that is the main active ingredient — has prevented the company from being able to meet the demand of its customer base, plus the addition of many patients who were formerly on Armour Thyroid.

According to company owner Rick Cox, with regarding to getting more natural desiccated thyroid drugs to market, “We are doing everything we can to move as quickly as we can, safely, to make it happen.” According to Cox, the company is estimating that they will have product availability within 90 days.